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Method for controlling quality of Chinese medicinal composition to treat cancerous pain and application thereof

A quality control method and composition technology, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as stagnation and unappeared varieties of traditional Chinese medicines

Active Publication Date: 2007-12-19
JIANGSU KANION PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, so far, such studies have mostly stayed on TCM theory or clinical prescriptions, and no TCM varieties that can achieve the same analgesic effect as opioids have yet appeared.

Method used

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  • Method for controlling quality of Chinese medicinal composition to treat cancerous pain and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0085] Embodiment 1: the preparation of composition injection

[0086] Take Qingfengteng 800g, celandine 700g and Chinese peach leaves 1000g three flavors, celandine and Qingfengteng add 8 times the amount of 80% ethanol to soak for 30 minutes, heat and reflux twice, each time for 2 hours, combine the alcohol extracts, Recover ethanol under reduced pressure and concentrate to 1:1, adjust pH 2-3 with 1mol / L phosphoric acid, let it stand for 12 hours, filter, adjust pH 10-11 with 40% sodium hydroxide solution, and extract 5 times with equal amount of chloroform, The chloroform solutions were combined, the chloroform was recovered, and the residue was vacuum-dried to obtain the total alkaloids. Add water to decoct Han peach leaves twice, each time for 1.5 hours, combine the decoction liquid, filter, concentrate the filtrate under reduced pressure, and use ethanol precipitation for two times. The alcohol content of the first solution reaches 60%, and the second time reaches 85%. ...

Embodiment 2

[0087] Embodiment 2: the identification of injection

[0088] A. Take 10ml of this pharmaceutical composition injection, adjust the pH value to 9-10 with 10% sodium hydroxide solution, add chloroform to extract 2 times, 10ml each time, combine the chloroform solution, evaporate to dryness, add 2ml of methanol to the residue to dissolve, as The test solution; take another 2g of Qingfengteng reference medicinal material and 5g of celandine reference medicinal material, add 1% hydrochloric acid solution 30ml and 50ml respectively, ultrasonically treat for 40 minutes, filter, add 10% sodium hydroxide solution to the filtrate to adjust the pH value To 9~10, add chloroform to prepare the reference medicinal material solution in the same way; then take sinomenine and chelidonine reference substances, add methanol respectively to make solutions containing 2mg and 1mg per 1ml, as the reference substance solution; according to thin-layer chromatography method test, draw 6 μl of each o...

Embodiment 3

[0090] Embodiment 3: the content determination of injection

[0091] A. Determination of sinomenine content

[0092] Chromatographic conditions and system suitability test: use octadecylsilane bonded silica gel as filler, use 15:85 acetonitrile-0.02M potassium dihydrogen phosphate as mobile phase: detection wavelength 265nm Theoretical plate number is based on sinomenine peak The calculation should not be less than 2000;

[0093] Preparation of reference substance solution: Accurately weigh an appropriate amount of sinomenine reference substance, add methanol to make a solution containing 0.5mg per 1ml, shake well, and obtain;

[0094] Preparation of the test solution: Accurately measure 1ml of the pharmaceutical composition injection, put it in a 10ml measuring bottle, add methanol to dilute to the mark, shake well, filter through a 0.45 μm microporous membrane, and use the filtrate as the test solution;

[0095] Determination method: Precisely draw 10 μl each of the refe...

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Abstract

The invention discloses a quality control method and equipment of traditional medicine component to treat cancer pain, which is composed of orientavine, greater celandine and dry peach leaf at the weight proportional ratio at 4-200: 5-230:10-250. The injection quality control method contains fingerprint atlas measuring method, identification method or content detecting method. The fingerprint atlas measuring method adapts high-effective liquid-phase chromatography to record the chromatogram, which calculates the relative keeping time and peak area ratio of joint fingerprint peak. The identification method contains the orientavine or dry peach leaf identification. The content measurement gauges the orientavine or chelidonine content. The invention is fit for preparing the lung cancer pain or liver cancer pain treatment medicine.

Description

field of invention [0001] The invention relates to a quality control method and application of a traditional Chinese medicine composition, in particular to a quality control method and application of a Chinese medicine composition for treating cancer pain. Background technique [0002] Pain is one of the most common and unbearable symptoms of cancer patients, and it is often more daunting than death caused by cancer. According to statistics, there are currently more than 7 million cancer patients in my country, and 51-62% of them are accompanied by varying degrees of pain, of which 40% are mild pain, 30% are moderate pain, and 30% are severe pain. The latest domestic data point out that only 41% of patients with cancer pain in my country are effectively relieved, while only 25% of patients with advanced cancer pain are effectively relieved. Cancer pain is different from general inflammatory pain. It is usually caused by the following reasons: direct tumor compression and ne...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 肖伟戴翔翎凌娅王振中毕宇安刘涛
Owner JIANGSU KANION PHARMA CO LTD
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